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SeaStar Medical is set to initiate a pilot study of its immunomodulating medical device in positive Covid-19 patients after receiving approval of its Investigational Device Exemption (IDE) supplement from the US Food and Drug Administration (FDA).
The study will assess the clinical activity, safety and tolerability of the Selective Cytopheretic Device (SCD) among target 35 adult subjects who have acute respiratory distress syndrome (ARDS) prior to continuous renal replacement therapy (CRRT) and / or acute kidney injury (AKI) with continuous renal replacement therapy (CRRT).
Reducing mortality rates and dialysis dependency and increasing ventilation-free survival include the primary objectives of the trial, which will be conducted in ten institutions in the US.
The company noted that many Covid-19 patients with ARDS are also prone to developing AKI and need renal replacement therapy. Approximately 40% to 60% of patients in intensive care units (ICU) are said to experience kidney failure due to the excessive release of cytokines.
Cytokines are small proinflammatory proteins released by cells to fight infection or injury. The overproduction of the proteins leads to a condition called cytokine storm or cytokine distress syndrome. It can cause excessive inflammation, which can be toxic and lead to multi-organ failure.
SeaStar Medical’s study is intended to analyse the use of the SCD to reduce and repair kidney injury.
The device selectively targets proinflammatory neutrophils and monocytes during CRRT. It improves and removes the cytokine storm that causes inflammation, organ failure and possible death in severely ill patients.
SeaStar Medical CEO Eric Schlorff: “We believe the SCD is the first immunomodulating device in renal care that can quell the storm and normalise the immune system to help repair kidney injury and prevent organ failure. We have observed preliminary evidence of what the SCD can do for patients.”
The previous clinical trial of the SCD reported reduced mortality and zero dialysis dependency at day 60 in adult patients with AKI requiring CRRT.
Currently, a Phase II clinical trial to evaluate the safety and efficacy of the SCD in paediatric patients with AKI and multi-organ failure is underway.